Schizophrenia Cognition Scale Development (CIAS PRO)

Schizophrenia Cognition Scale Development: Item Development and Psychometric Validation of a Novel Patient Reported Outcome (PRO) Measure for Research and Clinical Application

The objective of this protocol is to develop items for a patient-reported outcome (PRO) measure to assess the patient's perspective and subjective experience of cognitive impairment associated with schizophrenia (CIAS).

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Cognition Disorders

Detailed Description

Cognitive impairment associated with schizophrenia (CIAS) has been shown to be the strongest predictor of functional impairment among people with schizophrenia because it is associated with poor response to psychosocial interventions, employment status, and social functioning. Because the subjective experience of CIAS is likely to be associated with patient burden, distress, and motivation for treatment, it is important that this experience be assessed in a reliable and valid manner and from the perspective of the patient's self report. No existing instrument to assess CIAS has been developed with patient input directly about their qualitative experience of impaired cognition during the item generation stage, in accordance with FDA guidance for patient-reported outcome (PRO) measures.

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21285
      • Sheppard Pratt Health System
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Rutgers University Robert Wood Johnson Medical School
  • New York
    • Staten Island, New York, United States, 10312
      • Richmond Behavior Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with formal dx of schizo aged 18-55, stabe (non-acute phase), on stable medications

Description

Inclusion Criteria:

1. Patients with established diagnoses of schizophrenia (confirmed by the Structured Clinical Interview for DSM-IV [full version or Clinical Trial version] either performed as part of the study screening process or as documented in the medical record within 2 years prior to the study) with the following clinical features:

   • a)Clinically stable and in the residual (non-acute) phase of their illness for at least 8 weeks
   • b)Maintained on current antipsychotic and concomitant psychotropic medications for at least 6 weeks and on current dose for at least 2 weeks
   • c)Have no more than a ''moderate'' severity rating on hallucinations and delusions (e.g. Positive and Negative Syndrome Scale [PANSS] item scores < 5
   • d)Have no more than a ''moderate'' severity rating on positive formal thought disorder (e.g. Positive and Negative Syndrome Scale [PANSS] conceptual disorganization item score < 5)
   • e)Have no more than a ''moderate'' severity rating on negative symptoms (e.g., Positive and Negative Syndrome Scale-negative syndrome total score < 21)
   • f) Have no more than a minimal level of depressive symptoms (e.g. Calgary Depression Scale total score < 10); or, for eligibility for a waiting list, have a moderate level of depressive symptoms (e.g., Calgary Depression Scale total score between 10 and 15)
2. Male or female patients age 18 to 55 years
3. Exhibits reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures.
4. Able to provide informed consent

Exclusion Criteria:

1. Patient currently treated with more than two antipsychotic medications
2. Patient's cognitive impairment severity compromises the ability of the participant to participate meaningfully in a semi-structured interview, in the clinical judgment of the investigator
3. Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
4. Non-psychiatric disorders of the central nervous system (including but not limited to any kind of seizures, stroke, or traumatic brain injury)
5. Any other clinical condition that, in the opinion of the investigator, would jeopardize a patient's safety while participating in this study
6. In the 6 months prior, having met the criteria for dependence or abuse according to the DSM V in the opinion of the investigator.
7. Participation in another trial with an investigational drug or procedure within 30 days prior to screening or previous participation in any BI 409306 study
8. Unable to speak or read in English

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Impairment Associated with Schizophrenia	Using qualitative interview methods, adult subjects with a diagnosis of schizophrenia will provide self reported experience of cognitive impairments associated with schizophrenia. Domains and content will be identified and explored with the subjects and used to develop the PRO measure.	One time qualitative interivew within two weeks of screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Conceptual Model using Qualitative Interviews	Semi structured qualitative interviews will be conducted with adult subjects with schizophrenia. The results of the interviews will be analyzed using standard methods of inductive, iterative analysis. The results will serve as the basis for generating draft items for the PRO measure.	One time qualitative interivew
Assess content validity and comprehension of developed PRO measure	Following generation of draft PRO items, an independent series of qualitative interviews will take place in order to evaluate the draft items and ensure they accurately reflect the patient experience of cognitive impairment associated with schizophrenia.	One time qualitative interivew
Development and testing of a new patient reported outcome (PRO) measure	Using qualitative interview methods, adult subjects with a diagnosis of schizophrenia will provide self reported experience of cognitive impairments associated with schizophrenia. Domains and content will be identified and explored with the subjects and used to develop the PRO measure.	Patients will be interviewed within 2 weeks of consent

Collaborators and Investigators

• Sponsor: Carelon Research
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Raymond C Rosen, PhD, New England Research Institutes, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: April 16, 2014
• First Posted (Estimated): April 21, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders; Schizophrenia; Cognition Disorders
• Other Study ID Numbers: P1533

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No